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The Effects of Oxytocin in Obese Adults

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03043053
Collaborator
(none)
61
Enrollment
1
Location
2
Arms
60.2
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.

Condition or Disease Intervention/Treatment Phase
  • Drug: oxytocin nasal spray
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
May 20, 2022
Actual Study Completion Date :
Jul 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: oxytocin

oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)

Drug: oxytocin nasal spray
oxytocin intranasal spray
Other Names:
  • Syntocinon

    		•
    Placebo Comparator: placebo

    placebo nasal spray (4 times per day for 8 weeks)

    Drug: Placebo
    Placebo nasal spray

    Outcome Measures

    Primary Outcome Measures

    1. Mean difference in weight loss between Oxytocin and placebo 8 weeks after Baseline [Baseline to 8 weeks]

      The difference between the mean weight loss values between Oxytocin and placebo-treated groups at 8 weeks after Baseline

    Secondary Outcome Measures

    1. Change in resting energy expenditure after 8 weeks of Oxytocin versus placebo [Baseline to 8 weeks]

      Change in resting energy expenditure from Baseline to 8 weeks in the oxytocin versus placebo-treated groups

    2. Change in fat depots after 8 weeks of Oxytocin versus placebo [Baseline to 8 weeks]

      Change in fat depots from baseline to 8 weeks in the Oxytocin versus placebo-treated groups

    3. Difference in caloric intake after 8 weeks of Oxytocin versus placebo [Baseline to 8 weeks]

      Difference in caloric intake after 8 weeks of Oxytocin versus placebo treatment, mediated by change in fMRI activation of reward-related food motivation brain areas and impulse control

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18-45 years old;

    • BMI greater than or equal to 30 kg/m2

    Exclusion Criteria:

    • Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months);

    • history of medication changes within 4 weeks of enrollment;

    • active substance use;

    • history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease;

    • hematocrit >2% below normal;

    • fasting glucose > 125 mg/dL or hemoglobin A1c ≥ 7% ;

    • ALT or AST >2.5 times upper limit of normal;

    • Cr >1.5 mg/dL; hyponatremia;

    • pregnancy or breastfeeding;

    • unwilling to use medically acceptable form of contraception (females only)

    • follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet)

    • current smoking or tobacco use

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Elizabeth A Lawson, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elizabeth Austen Lawson, Associate Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03043053
    Other Study ID Numbers:
    • 2016P002810
    First Posted:
    Feb 3, 2017
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elizabeth Austen Lawson, Associate Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
    weight loss
    body mass index
    oxytocin
    magnetic resonance imaging
    Additional relevant MeSH terms:
    Oxytocin

    Study Results

    No Results Posted as of Aug 24, 2022